Summary

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding effect of ICOTYDE on fertility.
• The effect of ICOTYDE on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.¹

COMPANY CORE DATA SHEET

Animal Data

• In male rats, icotrokinra had no effects on mating, fertility, or early embryonic development of their offspring at oral doses up to 20 mg/kg/day (114 times the maximum recommended human dose [MRHD] based on area under the curve [AUC] comparison).¹ 
• In female rats, icotrokinra had no effects on estrous cyclicity, mating, fertility, or early embryonic parameters at oral doses up to 70 mg/kg/day (335 times the MRHD based on AUC comparison).¹ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 March 2026.